Existing methods and devices for creating and closing surgical incisions, particularly for surgical procedures involving soft tissue and internal organs, do not adequately protect patients from the associated health risks and complications, such as iatrogenic damage, ruptured organs, infections, tissue adhesion, and poor cosmetic appearance. Further, the current technology does not significantly decrease the time necessary to carry out many types of surgical procedures. Thus, the existing methods and devices do not reduce the various risks directly related to the duration of a surgical procedure.
Prior art methods and devices of closing surgical incisions include, for example, sutures, staples, tapes, and adhesives and energy-based sealants. However, these closure mechanisms are not sufficient prevention mechanisms against post-operative surgical site infections (SSI), the most common healthcare-associated infection in surgical patients. Patients who develop an SSI require significantly more medical care than those who are uninfected. For example, a surgical patient suffering from an SSI is 260 percent more likely to spend time in the intensive care unit after surgery than an uninfected patient. Further, a SSI increases the hospital length of stay for an infected patient by a median of two weeks. SSIs are particularly dangerous because they do not always develop immediately. Almost 2 percent of patients develop SSIs after they have been discharged from the hospital, and these patients are two to five times as likely to be readmitted to the hospital.
The prior art closure devices and methods suffer from several other deficiencies as well, particularly for certain types of procedures, such as those involving soft tissue and internal organs. Sutures may be risky because use can cause needlestick injury and subsequent infection to the medical personnel using them. Surgeons are also often faced with difficulty in repairing or closing incisions made for natural orifice trans-lumenal endoscopic surgery (NOTES), which results in lengthened surgery times and/or incision sites that have not been sufficiently hermetically sealed. Prior art devices also often fail to achieve proper post-operative healing, and may result in unsightly permanent scarring. Further, for procedures requiring subsequent and repeated access to the incision site, such access is often difficult when the incision has been closed with prior art mechanisms. Finally, the prior art closure mechanisms often involve multi-stage procedures and, thus, an additional hospital visit is typically required for removal of the closure mechanism.
Prior art devices and methods for making incisions also suffer from various additional deficiencies. With respect to caesarian procedures in particular, there have been reports of babies delivered by caesarian section who have been cut or wounded by the surgical incision device during the procedure. Further, it is often difficult for surgeons to make incisions for NOTES to gain laparotic entry through the internal organs of concern, without risking damage to other internal organs. Thus, there is an increase in the overall surgery time and an associated increase in the surgical risks and complications. Another type of surgical procedure for which prior art devices and methods are inadequate is a tubal resectioning procedure. Such procedures can take up to 10 hours because it can be difficult to make the accurate type of initial incision on dual lumen tubes as is necessary for perfect tissue presentation for closure.
Thus, there is a need for an incision device and a closure device, particularly for internal organ and soft tissue procedures, which enables medical personnel to efficiently and accurately create and close an incision, respectively, thus decreasing the overall length of time for a surgical procedure and the risk of infection. There is a further need for a closure device that achieves the necessary hermetic seal for organs and tissue which have been cut, thus resulting in a reduced risk of post-operative infections. There is also a need for a permanent closure mechanism that does not have to be subsequently removed by medical personnel, thus eliminating the need for an additional hospital visit and removal procedure.